A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)
Equfina Tablet 50 mg Post Marketing Surveillance Protocol
1 other identifier
observational
702
1 country
27
Brief Summary
The purpose of this study is to describe the following in relation to the safety of Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2021
CompletedFirst Submitted
Initial submission to the registry
January 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2025
CompletedJune 22, 2025
June 1, 2025
3.8 years
January 26, 2022
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.
From first dose of study drug up to 24 weeks
Number of Participants With ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
From first dose of study drug up to 24 weeks
Number of Participants With Unexpected AEs
An AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, which do not necessarily have a causal relationship with the drug in question. An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug.
From first dose of study drug up to 24 weeks
Number of Participants With Unexpected ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug.
From first dose of study drug up to 24 weeks
Number of Participants With Known ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs. Known ADRs are those listed in product licensure/notification of the drug.
From first dose of study drug up to 24 weeks
Number of Participants With Non-serious ADRs
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
From first dose of study drug up to 24 weeks
Secondary Outcomes (1)
Change From Baseline in Score of Clinical Global Impression of Change (CGIC)
Baseline up to 24 weeks
Study Arms (1)
Equfina 50 mg
Participants who will be prescribed with Equfina 50 mg tablets, orally within the scope of the approved label for Korea under the medical judgment of the investigator will be observed prospectively for 24 weeks.
Interventions
Eligibility Criteria
Participants administered with Equfina Tablet 50 mg tablet will be enrolled in this study.
You may qualify if:
- Participants with idiopathic Parkinson's disease experiencing end of dose motor fluctuations who are receiving Equfina Tablet 50 mg as adjunctive treatment to levodopa-containing products
- Participants who have given their consent to study participation about the use of personal data and medical data
You may not qualify if:
- Participants taking over monoamine oxidase (MAO) inhibitors (example, selegiline hydrochloric acid \[HCl\], rasagiline mesylate)
- Participants taking opioid drugs (example, pethidine HCl containing drugs, tramadol HCl containing products or tapentadol HCl)
- Participants taking serotonergic drugs (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitor, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, noradrenergic and serotonergic antidepressant) or psychostimulant drugs (example, methylphenidate HCl, lisdexamfetamine dimesylate)
- Participants taking dextromethorphan
- Participants with severe hepatic impairment (Child-Pugh C)
- Participants with a history of hypersensitivity to any of the ingredients of Equfina Tablet 50 mg
- Pregnant women or women who may be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Korea Inc.lead
Study Sites (27)
Site #23
Wŏnju, Gangwon-do, South Korea
Site #11
Ilsan, Gyeonggi-do, South Korea
Site #22
Yongin-si, Gyeonggi-do, South Korea
Site #06
Cheonan, Gyeongsangnam-do, South Korea
Site #09
Jinju, Gyeongsangnam-do, South Korea
Site #07
Yangsan, Gyeongsangnam-do, South Korea
Site #08
Iksan, Jeollabuk-do, South Korea
Site #17
Jeonju, Jeollabuk-do, South Korea
Site #18
Jeonju, Jeollabuk-do, South Korea
Site #26
Jeonju, Jeollabuk-do, South Korea
Site #03
Cheongju-si, North Chungcheong, South Korea
Site #05
Busan, South Korea
Site #16
Daegu, South Korea
Site #25
Daegu, South Korea
Site #20
Daejeon, South Korea
Site #19
Gwanju, South Korea
Site #24
Incheon, South Korea
Site #02
Jeju City, South Korea
Site #21
Sejong, South Korea
Site #01
Seoul, South Korea
Site #04
Seoul, South Korea
Site #10
Seoul, South Korea
Site #12
Seoul, South Korea
Site #13
Seoul, South Korea
Site #14
Seoul, South Korea
Site #15
Seoul, South Korea
Site #27
Ulsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2022
First Posted
February 4, 2022
Study Start
June 3, 2021
Primary Completion
March 20, 2025
Study Completion
March 20, 2025
Last Updated
June 22, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.